Pernille Heyckendorff Lilholt

Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial

BackgroundSeveral feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone.Methods/DesignThe present study is known as ‘TeleCare North’ in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight).DiscussionThere has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial.Trial registrationClinicaltrials.gov, http://NCT01984840, November 14, 2013.

Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish ‘TeleCare North’ cluster-randomised trial

Objective To assess the effect of telehealthcare compared with usual practice in patients with chronic obstructive pulmonary disease (COPD). Design A cluster-randomised trial with 26 municipal districts that were randomly assigned either to an intervention group whose members received telehealthcare in addition to usual practice or to a control group whose members received usual practice only (13 districts in each arm). Setting Twenty-six municipal districts in the North Denmark Region of Denmark. Participants Patients who fulfilled the Global Initiative for COPD guidelines and one of the following criteria: COPD Assessment Test score ≥10; or Medical Research Dyspnoea Council Scale ≥3; or Modified Medical Research Dyspnoea Council Scale ≥2; or ≥2 exacerbations during the past 12 months. Main outcome measures Health-related quality of life (HRQoL) assessed by the physical component summary (PCS) and mental component summary (MCS) scores of the Short Form 36-Item Health Survey, Version 2. Data were collected at baseline and at 12 month follow-up and analysed according to the intention-to-treat principle with complete cases, n=574 (258 interventions; 316 controls) and imputed data, n=1225 (578 interventions, 647 controls) using multilevel modelling. Results In the intention-to-treat analysis (n=1225), the raw mean difference in PCS from baseline to 12 month follow-up was −2.6 (SD 12.4) in the telehealthcare group and −2.8 (SD 11.9) in the usual practice group. The raw mean difference in MCS scores in the same period was −4.7 (SD 16.5) and −5.3 (SD 15.5) for telehealthcare and usual practice, respectively. The adjusted mean difference in PCS and MCS between groups at 12 months was 0.1 (95% CI −1.4 to 1.7) and 0.4 (95% CI −1.7 to 2.4), respectively. Conclusions The overall sample and all subgroups demonstrated no statistically significant differences in HRQoL between telehealthcare and usual practice. Trial registration number NCT01984840; Results.

User satisfaction and experience with a telehealth system for the Danish TeleCare North Trial: a think-aloud study.

The aim was to evaluate a redesigned version of Telekit--a telehealth system developed for the Danish TeleCare North Trial. Telekit is used in the management of care in patients diagnosed with chronic obstructive pulmonary disease (COPD). This paper summarises the experience and the feedback received from six COPD-participants in terms of usability and satisfaction. Participants were asked to think-aloud while performing some system specific tasks. After each session, participants completed a post-test questionnaire. The think-aloud test was recorded, and notes from the tests were categorised and analysed. All tasks were completed by participants. Difficulties were observed concerning monitoring of measurements and use of the touchscreen. User feedback was mainly positive, and nearly all participants perceived Telekit as very easy to use. The study provides important insight regarding use of Telekit by patients suffering from a chronic illness and increased understanding about, how similar systems can more effectively be used in such home health initiatives.

Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish ‘TeleCare North’ cluster-randomised trial

Objectives To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. Design A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Setting Community-based setting in the geographical area of North Denmark Region in Denmark. Participants 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. Interventions In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Main outcome measure Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. Results From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI −754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI −0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Conclusions Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. Trial registration Clinicaltrials.gov, NCT01984840, 14 November 2013.

Stratification of telehealthcare for patients with chronic obstructive pulmonary disease using a predictive algorithm as decision support: A pilot study

Introduction The number of patients needing care who suffer from chronic obstructive pulmonary disease (COPD) is expected to increase in the future. The consequences thereof will increase the socio-economic burden for both patients and society. Telehealthcare technologies have shown potential in reducing hospitalisation-related costs and in improving health-related quality of life (HRQOL) for some COPD patients, but not all. The aim of this study was to investigate the potential of predictive algorithms for helping the general practitioner to stratify telehealthcare for COPD patients in a way that maximises HRQOL and minimises COPD-related costs. Methods Data from 553 COPD patients based in the North Denmark Region were analysed and used as predictors for four multiple linear regression models. The models were trained and evaluated for their abilities to predict individual patient’s future health- and cost-related developments, with and without telehealthcare. Results The average root-mean-square error (RMSE) of the health and cost models was 5.265 HRQOL scores and US dollars (US

Subgroup analysis of telehealthcare for patients with chronic obstructive pulmonary disease: the cluster-randomized Danish Telecare North Trial

)5430.49, respectively. The accuracy regarding the polarity of the predicted changes ranged from 61–65% for the health models and 74–75% for the cost models. While differences in the magnitude of predictions with and without telehealthcare were statistically significant (p < 0.01), the polarity of predictions was similar across models in 82.05% of all cases. Discussion Our results indicate that it may be possible to predict the magnitude and polarity of a COPD patient’s future health- and cost-related developments with and without telehealthcare. Predictive algorithms may provide a useful decision support tool in stratifying telehealthcare for COPD patients.

Evaluation of a Telehealthcare Intervention for Patients with COPD: health- and patient-related evaluation of the Danish telecare north trial

Purpose Results from the Danish cluster-randomized trial of telehealthcare to 1,225 patients with chronic obstructive pulmonary disease (COPD), the Danish Telecare North Trial, concluded that the telehealthcare solution was unlikely to be cost-effective, by applying international willingness-to-pay threshold values. The purpose of this article was to assess potential sources of variation across subgroups, which could explain overall cost-effectiveness results or be utilized in future economic studies in telehealthcare research. Methods First, the cost-structures and cost-effectiveness across COPD severities were analyzed. Second, five additional subgroup analyses were conducted, focusing on differences in cost-effectiveness across a set of comorbidities, age-groups, genders, resource patterns (resource use in the social care sector prior to randomization), and delivery sites. All subgroups were investigated post hoc. In analyzing cost-effectiveness, two separate linear mixed-effects models with treatment-by-covariate interactions were applied: one for quality-adjusted life-year (QALY) gain and one for total healthcare and social sector costs. Probabilistic sensitivity analysis was used for each subgroup result in order to quantify the uncertainty around the cost-effectiveness results. Results The study concludes that, across the COPD severities, patients with severe COPD (GOLD 3 classification) are likely to be the most cost-effective group. This is primarily due to lower hospital-admission and primary-care costs. Telehealthcare for patients younger than 60 years is also more likely to be cost-effective than for older COPD patients. Overall, results indicate that existing resource patterns of patients and variations in delivery-site practices might have a strong influence on cost-effectiveness, possibly stronger than the included health or sociodemographic sources of heterogeneity. Conclusion Future research should focus more on sources of heterogeneity found in the implementation context and the way telehealthcare is adopted (eg, by integrating formative evaluation into cost-effectiveness analyses). Trial registration Clinicaltrials.gov, NCT01984840.

An Iterative, Mixed Usability Approach Applied to the Telekit System from the Danish TeleCare North Trial

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A pilot assessment of why patients choose not to participate in self-monitoring oral anticoagulant therapy

Objective. The aim of the present study is to evaluate the usability of the telehealth system, coined Telekit, by using an iterative, mixed usability approach. Materials and Methods. Ten double experts participated in two heuristic evaluations (HE1, HE2), and 11 COPD patients attended two think-aloud tests. The double experts identified usability violations and classified them into Jakob Nielsens heuristics. These violations were then translated into measurable values on a scale of 0 to 4 indicating degree of severity. In the think-aloud tests, COPD participants were invited to verbalise their thoughts. Results. The double experts identified 86 usability violations in HE1 and 101 usability violations in HE2. The majority of the violations were rated in the 0-2 range. The findings from the think-aloud tests resulted in 12 themes and associated examples regarding the usability of the Telekit system. The use of the iterative, mixed usability approach produced both quantitative and qualitative results. Conclusion. The iterative, mixed usability approach yields a strong result owing to the high number of problems identified in the tests because the double experts and the COPD participants focus on different aspects of Telekits usability. This trial is registered with Clinicaltrials.gov, NCT01984840, November 14, 2013.

Heuristic evaluation of a telehealth system from the Danish TeleCare North Trial

Patients suffering from heart diseases often face lifelong oral anticoagulant therapy. Traditionally, the patients general practitioner takes care of the treatment. An alternative management scheme is a self-monitoring setup where the patient monitors and manages the oral treatment himself. Despite international evidence of reduced thrombosis risk and death rate among patients enrolled in self-monitoring, a majority of eligible patients deselect this opportunity. Little is about the causes if this. This study is a pilot assessment of why patients, located in the North Denmark Region, choose not to participate. The study is based on qualitative interviews with two nurses working in a medical practice and two patients participating in conventional anticoagulant therapy. The results of this study seem to suggest that at least some patients feel a lack of information to base their decision regarding self-monitoring or conventional management on and that the knowledge among the health personnel at the medical clinics should be increased.